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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06183450
Other study ID # RC31/22/0252
Secondary ID 2023-A01415-40
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2024
Est. completion date January 2033

Study information

Verified date December 2023
Source University Hospital, Toulouse
Contact Mathieu Marx, Pr
Phone 05 61 77 77 04
Email marx.m@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. The results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders


Description:

The aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. This project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. The data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 262
Est. completion date January 2033
Est. primary completion date January 2033
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 50 Years
Eligibility Inclusion Criteria: - Normal hearing (Pure Tone Audiometry < or = 20 dB) - Residency in one of the three neighborhoods : - Affiliation with a social security system Exclusion Criteria: - Individuals under guardianship, trusteeship or curators - History of neurological pathologies - Taking of psychotropic medication.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
auditory level
Evaluation of auditory thresholds through audiometric tests. Evaluation of speech comprehension in noise through a vocal audiometry test in noise (FraMatrix). Evaluation of spatial auditory behavior and spatial precision using a spatial discrimination test (Minimum Audible Angle) and a static sound localization test in virtual reality.
cognitive level
Evaluation of attention and short-term memory functions with verbal and non-verbal tasks: Digit Span Test and Reading Span Test. Evaluation of inhibition capacities using the Stroop Test. Evaluation of executive functions, visual attention, reasoning, and mental arithmetic using the Raven's Matrix test.
quality of life level
- Evaluation of quality of live level via Speech, Spatial and Qualities of Hearing Scale (SSQ-12) and EuroQol-5D questionnaires.

Locations

Country Name City State
France Ecole d'audioprothèse Cahors

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pure-ton audiometry Pure-tone audiometry will be evaluated by collecting the threshold in air and bone conduction for both ears on each frequency tested (125-250-500-1000-2000-4000 and 8000 Hz), as well as the average hearing loss (MAP ) on all five frequencies. 5 years
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